Results Summary



Target vs. Comparator ~ Outcome [Analysis, DB]:

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 15,059 30,035 126 210 8.37 6.99 1.38
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 165 209 300 711 880 2,177
Comparator 4 180 228 321 728 903 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 15,055 30,004 118 217 7.84 7.23 1.38
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 165 209 300 711 879 2,177
Comparator 2 180 227 320 727 903 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,072 10,072 24,541 24,706 227 203 9.25 8.22 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 171 387 784 1,617 1,774 2,188
Comparator 15 154 378 797 1,638 1,774 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,072 10,072 24,551 24,700 216 213 8.80 8.62 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 172 385 784 1,620 1,774 2,188
Comparator 4 153 378 798 1,637 1,771 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,065 10,065 11,861 11,260 83 105 7.00 9.32 1.50
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 14 174 209 301 714 888 2,177
Comparator 2 152 207 298 664 802 2,175
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,065 10,065 11,863 11,276 100 96 8.43 8.51 1.49
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 174 209 301 715 889 2,177
Comparator 4 152 207 298 665 803 2,175
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 31,036 66,663 292 503 9.41 7.55 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 165 378 773 1,620 1,774 2,189
Comparator 2 189 453 938 1,726 1,888 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 31,028 66,715 297 495 9.57 7.42 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 165 377 773 1,621 1,774 2,189
Comparator 4 189 455 941 1,726 1,887 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,069 10,069 11,885 11,351 86 101 7.24 8.90 1.51
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 168 209 301 719 888 2,177
Comparator 2 153 207 300 675 825 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,069 10,069 11,888 11,357 96 102 8.08 8.98 1.49
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 168 209 302 719 890 2,177
Comparator 4 152 207 300 676 825 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 15,059 30,035 126 210 8.37 6.99 1.38
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 165 209 300 711 880 2,177
Comparator 4 180 228 321 728 903 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 15,055 30,004 118 217 7.84 7.23 1.38
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 165 209 300 711 879 2,177
Comparator 2 180 227 320 727 903 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,063 10,063 24,615 24,414 215 222 8.73 9.09 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 12 171 389 789 1,622 1,777 2,189
Comparator 7 154 373 789 1,620 1,767 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,063 10,063 24,582 24,448 234 206 9.52 8.43 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 171 385 787 1,624 1,777 2,189
Comparator 4 154 375 794 1,617 1,766 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 31,028 66,715 297 495 9.57 7.42 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 165 377 773 1,621 1,774 2,189
Comparator 4 189 455 941 1,726 1,887 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
12,844 24,760 31,036 66,663 292 503 9.41 7.55 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 165 378 773 1,620 1,774 2,189
Comparator 2 189 453 938 1,726 1,888 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 15,442 25,932 128 166 8.29 6.40 1.40
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 300 710 877 2,177
Comparator 2 206 231 335 781 964 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 15,429 25,914 125 203 8.10 7.83 1.37
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 161 209 300 710 875 2,177
Comparator 5 203 231 334 781 963 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,411 9,411 23,463 22,995 201 199 8.57 8.65 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 179 399 804 1,652 1,799 2,189
Comparator 5 165 384 798 1,613 1,760 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,411 9,411 23,440 23,034 218 201 9.30 8.73 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 14 181 397 801 1,652 1,799 2,189
Comparator 9 167 389 801 1,614 1,762 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,412 9,412 11,305 10,917 85 87 7.52 7.97 1.53
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 14 182 209 305 734 903 2,177
Comparator 5 164 207 306 705 853 2,188
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,412 9,412 11,314 10,919 94 80 8.31 7.33 1.53
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 182 209 305 735 906 2,177
Comparator 11 165 207 307 706 852 2,188
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 31,567 59,259 303 450 9.60 7.59 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 375 760 1,610 1,763 2,189
Comparator 2 224 510 1,034 1,841 1,984 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 31,580 59,152 300 488 9.50 8.25 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 161 376 760 1,610 1,763 2,189
Comparator 5 222 507 1,034 1,840 1,985 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,418 9,418 11,223 10,891 95 79 8.46 7.25 1.53
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 177 209 302 724 901 2,177
Comparator 11 166 208 309 696 843 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,418 9,418 11,218 10,867 83 98 7.40 9.02 1.52
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 14 175 209 301 724 898 2,177
Comparator 5 165 208 307 692 843 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 15,429 25,914 125 203 8.10 7.83 1.37
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 161 209 300 710 875 2,177
Comparator 5 203 231 334 781 963 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 15,442 25,932 128 166 8.29 6.40 1.40
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 300 710 877 2,177
Comparator 2 206 231 335 781 964 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,408 9,408 23,460 22,896 216 202 9.21 8.82 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 14 178 399 804 1,655 1,803 2,189
Comparator 11 165 384 789 1,616 1,764 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
9,408 9,408 23,463 22,833 211 214 8.99 9.37 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 176 398 804 1,654 1,803 2,189
Comparator 5 165 383 784 1,615 1,762 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 31,567 59,259 303 450 9.60 7.59 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 375 760 1,610 1,763 2,189
Comparator 2 224 510 1,034 1,841 1,984 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
13,198 20,237 31,580 59,152 300 488 9.50 8.25 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 161 376 760 1,610 1,763 2,189
Comparator 5 222 507 1,034 1,840 1,985 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 49,736 108,680 319 455 6.41 4.19 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 209 302 711 880 2,189
Comparator 2 201 232 339 802 990 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 49,706 108,643 316 502 6.36 4.62 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 209 302 711 878 2,189
Comparator 1 200 232 339 802 990 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,012 32,012 82,322 79,777 540 533 6.56 6.68 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 166 397 839 1,718 1,861 2,190
Comparator 2 141 374 802 1,683 1,835 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,012 32,012 82,356 79,854 552 520 6.70 6.51 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 166 397 839 1,719 1,862 2,190
Comparator 2 141 375 803 1,685 1,839 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,033 32,033 37,914 36,974 216 211 5.70 5.71 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 165 209 303 716 885 2,189
Comparator 2 140 207 305 697 848 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,033 32,033 37,908 36,945 212 223 5.59 6.04 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 303 717 885 2,189
Comparator 2 140 207 305 697 849 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 106,234 256,456 766 1,272 7.21 4.96 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 384 808 1,694 1,840 2,190
Comparator 2 221 539 1,127 1,942 2,062 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 106,154 256,282 757 1,267 7.13 4.94 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 384 808 1,693 1,839 2,190
Comparator 1 221 538 1,126 1,942 2,063 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,006 32,006 37,949 37,166 222 220 5.85 5.92 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 167 209 304 717 888 2,189
Comparator 2 143 207 307 698 857 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,006 32,006 37,943 37,137 202 219 5.32 5.90 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 166 209 304 717 888 2,189
Comparator 2 144 207 307 698 857 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 49,706 108,643 316 502 6.36 4.62 1.23
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 209 302 711 878 2,189
Comparator 1 200 232 339 802 990 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 49,736 108,680 319 455 6.41 4.19 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 209 302 711 880 2,189
Comparator 2 201 232 339 802 990 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,014 32,014 82,248 79,444 540 539 6.57 6.78 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 167 397 837 1,715 1,861 2,190
Comparator 2 140 368 798 1,673 1,813 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
32,014 32,014 82,293 79,553 544 540 6.61 6.79 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 167 397 836 1,719 1,863 2,190
Comparator 2 140 370 798 1,677 1,816 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 106,154 256,282 757 1,267 7.13 4.94 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 384 808 1,693 1,839 2,190
Comparator 1 221 538 1,126 1,942 2,063 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Etanercept (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
42,290 83,140 106,234 256,456 766 1,272 7.21 4.96 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 160 384 808 1,694 1,840 2,190
Comparator 2 221 539 1,127 1,942 2,062 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Etanercept (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 48,404 122,177 310 530 6.40 4.34 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 303 712 879 2,189
Comparator 1 187 231 325 726 906 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 48,387 122,130 297 555 6.14 4.54 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 209 303 712 878 2,189
Comparator 2 187 230 325 725 906 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,129 33,129 84,271 82,587 573 559 6.80 6.77 1.18
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 390 824 1,706 1,852 2,190
Comparator 1 146 369 806 1,687 1,841 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,129 33,129 84,280 82,556 546 575 6.48 6.96 1.18
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 391 826 1,706 1,849 2,190
Comparator 3 146 369 805 1,686 1,839 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,127 33,127 38,944 37,200 218 236 5.60 6.34 1.30
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 162 209 301 711 875 2,189
Comparator 3 145 207 304 662 810 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,127 33,127 38,943 37,228 245 216 6.29 5.80 1.30
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 302 711 875 2,189
Comparator 1 145 207 304 662 810 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 104,149 281,323 732 1,366 7.03 4.86 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 389 822 1,705 1,848 2,190
Comparator 2 198 474 998 1,796 1,959 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 104,221 281,443 751 1,336 7.21 4.75 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 389 822 1,705 1,852 2,190
Comparator 1 199 474 998 1,797 1,960 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,115 33,115 38,945 37,305 215 220 5.52 5.90 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 209 301 711 874 2,189
Comparator 2 144 208 303 665 819 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,115 33,115 38,932 37,319 242 219 6.22 5.87 1.30
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 301 711 873 2,189
Comparator 1 144 208 304 665 821 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 48,387 122,130 297 555 6.14 4.54 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 209 303 712 878 2,189
Comparator 2 187 230 325 725 906 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 48,404 122,177 310 530 6.40 4.34 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 209 303 712 879 2,189
Comparator 1 187 231 325 726 906 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,121 33,121 84,219 82,673 549 564 6.52 6.82 1.18
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 389 825 1,706 1,852 2,190
Comparator 3 147 375 810 1,684 1,831 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
33,121 33,121 84,257 82,688 568 563 6.74 6.81 1.18
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 389 824 1,707 1,854 2,190
Comparator 1 146 375 810 1,685 1,831 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 104,149 281,323 732 1,366 7.03 4.86 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 164 389 822 1,705 1,848 2,190
Comparator 2 198 474 998 1,796 1,959 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
41,071 99,812 104,221 281,443 751 1,336 7.21 4.75 1.14
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 164 389 822 1,705 1,852 2,190
Comparator 1 199 474 998 1,797 1,960 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier